Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2025-12-24 @ 3:24 PM
NCT ID:
NCT04579692
Brief Summary:
The purpose of this study is to assess the safety and effectiveness of MRI-guided focused ultrasound (MRgFUS) for treating Trigeminal Neuralgia. Trigeminal Neuralgia (pain) is a type of pain involving the face that can be disabling to those it affects.
Detailed Description:
The purpose of this study is to assess the safety and effectiveness of MRI-guided focused ultrasound (MRgFUS) for treating Trigeminal Neuralgia. Trigeminal Neuralgia (pain) is a type of pain involving the face that can be disabling to those it affects.
Usually, people with trigeminal pain receive medicines to control the pain. However, these medications may not give adequate pain relief. They may have unwanted side effects. In many patients with Trigeminal Neuralgia, a blood vessel compressing the nerve could be responsible for this condition. In such patients, surgery (also called micro-vascular decompression) is considered to be the best option if the medications do not control the pain. However, not all patients are good candidates for surgical correction and some patients may have recurrence of pain following surgical correction.
When surgery is not possible or recommended, other procedures are also available to patients. Such procedures usually result in selective damage to the nerve pain fibers in the Trigeminal nerve. Examples of these treatments include injection of materials such as Glycerol into the nerve, compression of the nerve with a balloon or selective radiation treatment of the nerve (stereotactic Radiosurgery). These treatments may not always improve the patient's pain or may only relieve the pain for a short duration of time.
These treatments may also result in damage to the nerve fibers that carry sensation from the face.
Our study will assess a new device for treating patients who have disabling pain that has not responded to medications or medications along with surgery. The device we will assess is called the ExAblate Transcranial focused ultrasound system. In this study, we will use this device to send ultrasound waves through the skull to precisely target and treat a tiny area of the brain called central lateral nucleus.
Study:
NCT04579692
Study Brief:
Protocol Section:
NCT04579692